No Warning Added By FDA To Drug Label For Actemra About Pancreatitis

July 12, 2017 By Law Offices of Thomas J. Lamb, P.A.

An insightful article by reported Charles Piller, “Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients”, published June 5, 2017 online by STAT, put the spotlight on some serious but little-known side effects associated with this medicine from Genentech, Inc.

From that recent article we get this rather alarming safety information about Actemra:

… STAT analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and found clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs.

Most of those medications warn about these risks on their labels. Actemra does not.

Consumers are barraged every day with drug ads accompanied by numbing lists of side effects, but STAT’s investigation shows that the risks to patients might be greater than they are led to believe. The Food and Drug Administration has received reports on 1,128 people who died after taking Actemra, and has reviewed its safety several times since it was approved. But the agency doesn’t have sophisticated tools to determine whether the drug was a culprit or a bystander in those deaths….

Experts who examined the data at STAT’s request said the FDA should immediately consider warnings for heart failure and pancreatitis — an inflammation of the pancreas that in its acute form can kill up to 50 percent of patients. They said the evidence that Actemra might increase the risk of heart attacks, strokes, and interstitial lung disease, a sometimes-fatal scarring of lung tissue, is less convincing but warrants further review.

This focus on Actemra side effects and the lack of warnings about these adverse reactions shines the light on the apparent inadequate standards of post-marketing surveillance for drugs approved by the FDA.

We are interested in hearing about patients who were diagnosed with pancreatitis or some other serious side effect while using Actemra. You can do this by submitting a Quick Contact Form or by using the Email link found in the sidebar.

Attorney Tom Lamb

Mr. Lamb is recognized by other lawyers as practicing law at the highest level of professional experience in terms of legal ability and ethical standards — which is indicated by an AV® Preeminent™ 5.0 out of 5 rating (highest classification) rating from the Martindale-Hubbell® Lawyer Directory.

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